Asia & its patient recruitment potential for clinical trials

In today’s whitepaper release, featured company ClinActis, shares their insight on patient recruitment strategies in Asia and the possible approaches for the different regions in APAC.

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According to the 2012 Tufts CSDD study, clinical site activation rates in Asia Pacific are at one of the highest, with 91% of sites successfully progressing through the study start up stages and recruiting the first patients in at speed. Not only are site activation rates high but Investigative sites operating in this region achieved, or exceeded, target enrolment levels at 108%, making it the top region in that respect.

Despite these figures demonstrating the Asia Pacific region has great recruitment potential, as clinical research activities in the region grow and with the increase of more complex protocols, it is necessary to emphasise the importance of focusing on Patient Recruitment. Ensuring, that like the US and Europe, additional support is provided in this speciality for the conduct of successful clinical trials throughout the region. Learning from how these issues developed and are being resolved in the currently saturated markets, should be a key starting point.

More so than other regions, Asia Pacific is made up of a large number of diverse cultures, therefore when considering patient engagement there are many patient and physician motivations and rules of interactions to understand. Targeted patient recruitment and retention strategies need to be tailored from country to country and will also vary dependent on the indication of the target patient.

For certain therapeutic areas, recruitment strategies need to have a different strategy and approach. For example, with a traumatic brain injury (TBI) study patients are recruited upon emergency hospital admission, so instead of relying on hospital databases, focus needs to be on ensuring all TBI cases which come in are reviewed for eligibility. In Hong Kong, a site set up a ‘call’ system, so as soon as a case would be admitted, the investigator would be alerted to review the patient for eligibility 24/7. In Singapore, posters were put up around the neuro-surgery department to act as a constant reminder to doctors working on the trial. In the Philippines, the majority of patients are unable to pay for hospitalization and associated care, so participation alone would be a source of finance assistance and allow for the patient’s potential survival. Therefore in this country, it was important to create a strong awareness of the study and set up a good referral system. In addition, pre-screening logs were provided to all sites to ensure all TBI cases were reviewed and clear reasons had to be noted for excluding such patients.

For the purpose of this article, we would like to look at countries in this region which have been less explored and discussed until recently, with the number of clinical trials in each of these increasing rapidly. Much of this recent growth has been contributed by governments encouraging and incentivising clinical trials.

In terms of Patient Recruitment, these countries can be split into two tiers. The first tier is made up of Hong Kong, Singapore, Taiwan and Korea. With regards to infrastructure, medical care, regulatory set up and technology, these are the more developed countries of the region. Sites work as part of a centralised healthcare system with high-quality facilities and investigators.

For this tier a mix of traditional and new media would work best:

Posters in public transport and stations, as well as hospitals;

Newspapers;

Outreach to patient advocacy groups, including advertising on their websites;

Some hospitals have TVs for outpatient cases, so recruitment videos can be screened;

Community outreach: Internet, workshops and support groups;

Phone Applications;

Social media.

Social media can work as both a direct and indirect tool. Once such example is in relation to a recent infant nutrition study. One of the mothers, who’s child was taking part, was so excited to join the trial that she posted trial information to her Facebook group, encouraging other mothers to join so they too could receive the ‘free milk powder’.

Even in these more developed countries it is important to increase public awareness and educate about clinical trials. One such effort to do so can be seen in Singapore hospitals, with some of the larger walls painted with information on clinical trials for all hospital visitors to see. This idea could potentially be replicated on buses and would also work well in 2nd tier countries.

The second tier is comprised of the Philippines, Thailand, Indonesia, Vietnam and Malaysia. This group of countries are less developed in general, although there are pockets of the population with which have ready access to new technology. In order to cast a wider net, it means the more traditional patient recruitment tools will be more successful for the moment:

It is particularly important to increase the visibility of trials in these countries, with the best way of doing so though posters in hospitals. Printed traditional media in the form of educational brochures in the local language will also work well.

Motivational visits from the Sponsor or the CRO representative can also prove invaluable to keep the sites and their staff motivated.

Word of mouth or referrals work best in these countries. An example of this is with a dengue vaccine trial which was conducted in Malaysia where the site coordinator visited local villages to initially recruit subjects. The site coordinator then continued to visit them regularly to keep participants interested in the study.

Across all Asian cultures, physicians hold a very high place in society and all patients put their complete trust in their doctors. This can work in the advantage of both patient recruitment and retention. In Asia more of an emphasis must be placed on the informed consent process, ensuring site staff are sufficiently trained in this area and are educating trial subjects early on.

Assigning a dedicated study coordinator to each trial subject can help create a sense of familiarity for the patients, this also helps them build a strong rapport so they are more likely to return for subsequent visits. It is important to make it personal, creating a caring atmosphere. For an infant nutrition study, this was done by providing birthday cards to the sites for them to send out to the children on their birthdays.
Many patients feel left in the dark about the study they are participating in and want to know how they are contributing to the bigger picture. For tier 1 countries it could be a good idea to set up a study website in order to update the patients on the trial’s progress. For tier 2 countries, the same affect can be created via regular newsletters being sent out to the patients. In both cases, study coordinators should also be available to assist the sites with any questions, either from the sites themselves or the patients.

Another idea, which would work well across both tiers, would be to hold patient meetings at each of the sites. This will also help with motivation and encourage compliance. It creates a sense of community, allows all patients participating in the study to meet each other and share experiences. At the same time it lets site staff re-enforce any important messages, for example on special procedures etc. This was recently done with a study in Diabetes in China and there was a clear correlation between sites where this tool was implemented and the retention rate.

A similar tool can be applied for Investigator motivation. Organising meetings or teleconferences, at regular intervals throughout the study duration, allows all Investigators and site personnel to share their study experiences, inspire and problem solve. This can help ‘re-energise’ the sites.

Building in efficiencies can also really help motivate patients come to their follow up visits, ensuring the visits as hassle free as possible. In Singapore, as with other countries, infants need to follow a compulsory vaccination schedule. As part of a paediatric study one PI thought that if you incentivise the parent/infant by allowing them to have one of these vaccinations at the same time as the study visit, they would be more likely to come. In this case it saved them the time of making a separate visit to a different clinic and therefore contributed to the low drop-out rates for this study.

With 60% of the world population and a hotbed of diseases associated with both the developing and developed countries, Asia Pacific is becoming a more and more attractive market to conduct research in. With this comes the already steady increase of clinical trials being conducted in the region. We need to look at the lessons learned in the US and Europe and start address issues at the beginning of a study, rather than when they occur. As a starting point it is important that Sponsors and CROs alike put specific Patient Recruitment SOPs in place and also really closely monitor activities in the region. As an emerging region, the majority of countries are developing all the time and some at speed, so what works best needs to be continually assessed. The key being patient and site centricity; creating a community for each study and making everyone feel involved.

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To learn more about Asia and its Patient Recruitment potential for Clinical Trials in Asia, reach out to ClinActis at the BioPharma Asia Convention 2015 on 24 – 25 March, Singapore